Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis

Phase 1

Conditions: moderate to severe palmoplantar psoriasis
MedDRA version: 18.0Level: LLTClassification code 10037158Term: Psoriasis palm & solesSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2012-005412-25-PT

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 201

Inclusion Criteria

•Men or women at least 18 years at the time of screening
•Subjects should have chronic moderate to severe plaque type psoriasis for at least 6 months prior to entering the study, including significant involvement of plaque type psoriasis on the palms and soles defined by a palmplantar Investiator Global Assessment (ppIGA) score of > 3 (on a 5-point scale) and at least one extra palmoplantar plaque on the skin
•Subjects should be candidates for systemic therapy, which means having psoriasis considered inadequately controlled by topical treatment (including super potent topical corticosteroid) and/or phototherapy and/or previous systemic therapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 191
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis)
•Drug-induced psoriasis (e.g. new onset or current exacerbation from ß-blockers, calcium channel inhibitors or lithium)
•Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods have to be adhered to.
•Prior exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or IL-17 Receptor
•Receipt of any investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer
•Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
•History of hypersensitivity to constituents of the study treatment. Other protocol-defined inclusion/exclusion criteria may apply